Suture coil and suture sheath for tissue repair

ABSTRACT

A medical device is provided comprising a suture thread coated with a stiffening agent and having a shape of a coil having a plurality of windings. The suture thread may be used to reconnect soft tissue to bone tissue. The suture thread may be used in conjunction with a suture sheath which is inhibited from movement relative to the suture thread.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority of U.S. provisionalapplication No. 61/469,386, filed Mar. 30, 2011, the teachings of whichare incorporated herein by reference.

FIELD

This disclosure relates to systems, devices and methods for the repairof defects that occur in tissue of a body, particularly a human body.

BACKGROUND

In tissue repair, to repair a torn rotator cuff of a shoulder, surgeonsmay reattach the supraspinatus tendon to the humerous of a body.Preferably, an attachment method should offer sufficient strength with aminimal amount of foreign hardware in the construct, to minimizerejection by the body. As such, the use of tranosseous sutures may bepreferred to mechanical anchors to reattach the supraspinatus tendon tothe humerous.

With the use of transosseous sutures, transosseous tunnels may be formedin the humerous. There are numerous methods of generating bone tunnels,however, the challenge often lies with the means of shuttling suturethrough the prepared blind bone holes. Known methods are generallyunfavorable due to size, cost or overall reliability. They are sometimescumbersome, particularly when trying to retrieve a loose end of thesuture thread.

SUMMARY

The present disclosure may provide systems, devices and methods totissue repair, particularly to reattach soft tissue to bone. Moreparticularly, the present disclosure may provide systems, devices andmethods to reattach soft tissue such as connective tissue to bone suchas the pelvis, a vertabrae or a long bone which may include thehumerous, femur and tibia. Specific examples may include reattaching thesupraspinatus tendon to the humerous to repair a torn rotator cuff aspart of shoulder surgery; reattaching an anterior cruciate ligament or amedial collateral ligament to the femur or tibia as part of kneesurgery; or rettaching a bicep tendon to the glenoid or elbow.

In one embodiment, the present disclosure may provide a suture threadcoated with a stiffening agent to increase a rigidity of the suturethread. The suture thread may be formed into self-supportingpredetermined shape, such as a coil. The suture coil may then beintroduced into a first blind bone bore and retrieved from a secondblind bone bore intersecting the first blind bone bore, which creates acontinuous tissue tunnel having an opening at each end thereof. Thesuture coil may be retrieved with a suture retriever having a helicalcoil or “cork screw” at the distal end thereof. The coil may function asa hook at the distal end of the suture retriever which may be rotated topresent several opportunities for the retriever coil to engage thesuture coil and successfully pass the suture thread from the first blindbone bore to the second blind bone bore. The space required to achievethis union can be very small, and may be considered as being moreminimally invasive, when being compared to other repair options.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention are set forth bydescription of embodiments consistent with the present invention, whichdescription should be considered in conjunction with the accompanyingdrawings wherein:

FIG. 1 is a side view showing a suture thread formed on a mandrel into asuture coil according to the present disclosure;

FIG. 2 is a side view of the suture thread of FIG. 1, including thesuture coil, having a stiffening agent applied thereto according to thepresent disclosure;

FIG. 3 is a side view of the suture thread of FIG. 1, including thesuture coil, with the stiffening agent applied thereto and the mandrelremoved according to the present disclosure;

FIG. 4 is a side view of the suture thread of FIG. 1 with a loose endsection of the suture thread passed through the suture coil to form aclosed end loop at one end of the suture coil according to the presentdisclosure;

FIG. 5 is a close-up perspective view of the suture thread of FIG. 1with the end section of the suture thread passed through the suture coilsuch that the closed loop is now at the end of the coil according to thepresent disclosure;

FIG. 6 is a cross-sectional view of a bone, particularly a humerous,with the suture thread formed into the suture coil of FIG. 1 insertedinto a first bone tunnel and a suture retriever device inserted into asecond bone tunnel according to the present disclosure;

FIG. 7 is a close-up cross-sectional view of the bone with the suturethread formed into the suture coil of FIG. 1 inserted into the firstbone tunnel and the suture retriever device inserted into the secondbone tunnel according to the present disclosure;

FIG. 8 is a side view of a distal end portion of a suture retrieverdevice according to the present disclosure;

FIG. 9 is a side view of a distal end portion of another sutureretriever device according to the present disclosure;

FIG. 10 is a close-up cross-sectional view of the bone with the suturethread formed into the suture coil of FIG. 1 inserted into the firstbone tunnel and a suture retriever device inserted into the second bonetunnel with the suture coil retrieved by the suture retriever deviceaccording to the present disclosure;

FIG. 11 is a side view of a suture thread and first suture reinforcingtube according to the present disclosure;

FIG. 12 is side view of a suture thread and another suture reinforcingtube according to the present disclosure;

FIG. 13 is a side view of a suture thread and another suture reinforcingtube according to the present disclosure; and

FIG. 14 is a side view of a suture thread and a suture reinforcing tubeaccording to the present disclosure in combination with a reinforcingplate and tissue.

DETAILED DESCRIPTION

It may be appreciated that the present disclosure is not limited in itsapplication to the details of construction and the arrangement ofcomponents set forth in the following description or illustrated in thedrawings. The embodiments herein may be capable of other embodiments andof being practiced or of being carried out in various ways. Also, it maybe appreciated that the phraseology and terminology used herein is forthe purpose of description and should not be regarded as limiting.

Referring now to FIG. 1, a suture thread 10 may be wound or otherwiseformed into the shape of a spiral (helical) coil 12. Suture thread 10may be formed into the shape of a coil 12 by being wrapped around asuitable forming mandrel 14, such as a cylindrical rigid rod made ofmetal, plastic or ceramic.

As shown, suture coil 12 may have a length defined by a plurality ofcircular windings 16 arranged along a longitudinal axis 18 of formingmandrel 14. Windings 16 may be of uniform diameter and arrangedside-by-side, particularly with adjacent windings 16 in contact with oneanother. The outside diameter OD of suture coil 12 may be in a range of,for example, 1 mm to 6 mm (more particularly, 1 mm to 3 mm) and theinside diameter ID of the suture coil 12 may be in the range of, forexample, 0.5 mm to 5.5 mm. The suture coil 12 may have a length from,for example, 2 mm to 25 mm and may be made of a suture thread 10 havinga diameter from, for example, 0.1 mm to 2 mm.

The suture thread 10 may be made of a nonabsorbable or absorbablematerial (a material which has a substantial decrease in tensilestrength within 60 days under the skin). The suture thread 10 may be amonofilament, or may be made of multiple filaments (e.g. twisted orbraided) together. The suture thread 10 may be made of nature orsynthetic materials, including polymers. Exemplary nonabsorbable suturethread 10 may be made of silk (e.g. flexible multifilament, braided ortwisted, composed of organic protein such as fibroin), nylon,polypropylene, polyester and polybutester. Exemplary absorbable suturethread 10 may be made of catgut (e.g. collagen strands), chromic gut,polyglycolic acid, polyglactic acid, polydioxanone and polyglyconate.

Referring now to FIG. 2, after being formed into the shape of a coil 12,a stiffening agent 20 may be applied (e.g. sprayed) to the outer surface24 of the windings 16 of suture coil 12 to form a coating 26 thereon.Stiffening agent 20 may increase the rigidity of the suture thread 10and hold the position of the windings 16 stationary and fixed relativeto one another so that the suture thread 10 may be removed from theforming mandrel 14 without substantial deformation thereof. For example,suture thread 10 may be made sufficiently rigid with stiffening agent 20such that suture coil 12 does not deform under its own weight withmanipulation thereof and windings 16 do not separate or change in size(e.g. diameter).

The stiffening agent 20 may be sprayed or otherwise applied to the outersurface 24 of the suture thread 10 as a liquid containing volatilecompounds which thereafter air dries (e.g. through the evaporation ofthe volatile compounds) leaving behind coating 26 which stiffens as itsolidifies. The stiffening agent 20/coating 26 may comprise one or morenature or synthetic polymers such as polyvinylpyrrolidone (PVP, alsocalled polyvidone), polydimethylsiloxane (PDMS), copolymers with vinylacetate and maleic anhydride and vegetable gums dissolved in alcohol.

Alternatively, the stiffening agent 20 may be applied to the suturethread 10 as a heated melt, such as a polymer melt with a temperatureabove melt temperature, which solidifies as it cools to provide apolymer coating 26 and does not have an evaporative carrier. In thismanner, the stiffening agent 20, which may comprise a thermoplasticpolymer, may be applied the suture thread 10 prior to the suture thread10 being formed into suture coil 12. Thereafter, the suture thread 10with thermoplastic coating 26 may be reheated (e.g. above roomtemperature and below melt temperature) prior to and during theformation of suture coil 12, and then be subsequently cooled (e.g. toroom temperature) after formation of suture coil 12.

Referring now to FIG. 3, once the suture coil 12 is formed andstiffening agent 20 has been applied to maintain the form (shape) of thecoil 12, the suture coil 12 may be removed from mandrel 14. The mandrel14 may include a stick-resistant coating on the outer surface thereof,such as a PTFE coating, to inhibit the suture coil 12 from sticking tothe mandrel 14.

The suture thread 10 with suture coil 12 may include uncoiled terminalend sections 30 and 32 at each end of the coil 12. As shown in FIG. 4,uncoiled section 32 may be passed through the inner passage 34 of thecoil 12 (previously occupied my mandrel 14) to form a closed loop 36 atone end of the suture coil 12 and have both end sections 30 and 32 atone common end of coil 12. Alternatively, as shown in FIG. 5, endsection 32 may be passed through the inner passage 34 of the coil 12such that the loop 36 is now at the end of the coil 12 (i.e. formed by awinding 16).

Referring now to FIG. 6, the suture coil 12 may then be inserted into anopening 42 of a first linear (straight) cylindrical blind bore passageor bone tunnel 44 in bone 50, which may be formed by a drill. A distalend portion 46 of the bone tunnel 44 may be intersected by the distalend portion 56 of a second linear (straight) cylindrical blind borepassage or bone tunnel 54 having opening 52, which may also be formed bya drill. In the foregoing manner, a non-linear continuous tissue tunnelhaving an opening at each end thereof is formed, and suture thread 10including suture coil 12 may then pass through bone tunnel 44 and intobone tunnel 54 where it may subsequently exit from opening 52. As shown,bone tunnels 44 and 54 are formed at an angle relative to one another,here acute, and do not share a common longitudinal axis. Depending onthe size of coil 12, bone tunnels 44 and 54 may have a slightly largerdiameter (e.g. 0.1-2 mm). For example, the inside diameter in a rangeof, for example, 1.1 mm to 8 mm.

As shown in FIGS. 6 and 7, in order to more easily pass suture coil 12through bone tunnel 54 so that it may exit from opening 52, a sutureretriever device 60 may be inserted into bone tunnel 54 to make contactwith suture coil 12. As best shown in FIG. 7, suture retriever device 60comprises a helical coil 62 at the distal end of a shaft 64, with coil62 having a distal pointed end 68. As shown in FIG. 8, the distal end 68of coil 62 may be linear and project distally or, as shown in FIG. 9,may arc proximally with a hook configuration.

Referring now to FIG. 10, in order to engage and retain suture coil 12with suture retriever device 60, retriever device 60 may be rotatedwithin bone tunnel 54, here counterclockwise (relative to the user),until a portion 70 of a winding 16 of the suture coil 12 is hooked bycoil 62. In order to hook suture coil 12, for example, distal end 68 ofcoil 62 may enter passage 34 from the end of suture coil 12 andthereafter hook a winding 16 thereof. Alternatively, distal end 68 ofcoil 62 may pass between two adjacent windings 16 to hook a winding 16.Thereafter, suture thread 10 may be extracted through bone tunnel 54 andfrom opening 52 as suture retriever device 60 is retracted from bonetunnel 54 and opening 52.

Thus, the present disclosure may provide a suture thread 10 coated witha stiffening agent 20 to increase a rigidity of the suture thread 10.The suture thread 10 may be formed into a suture coil 12. The suturecoil 12 may then be introduced into a first blind bone bore 44 andretrieved from a second blind bone bore 54 intersecting the first blindbone bore 44. The suture coil 10 may be retrieved with a sutureretriever device 60 having a helical coil 62 at the distal end thereof.The coil 62 may function as a hook at the distal end of the sutureretriever device 60 which may be rotated to present severalopportunities for the retriever coil 62 to engage the suture coil 12 andsuccessfully pass the suture thread 10 from the first blind bone bore 44to the second blind bone bore 54. The space required to achieve thisunion can be very small, and may be considered as being more minimallyinvasive, when being compared to other repair options.

In certain embodiments, once the suture thread 10 is extracted throughbone tunnel 54 from opening 52, one of the end sections 30, 32 of thesuture thread 10 may now be pulled though bone tunnels 44 and 54 suchthat one end section 30 of the suture thread extends from bone tunnel 44and the other end section 32 extends from bone tunnel 54, during whichtime at least a portion of the coil 12 may be uncoiled to pull thesuture thread taught from each bone tunnel 44 and 54 and more easilyslide within. Thereafter, the suture thread 10 may be used to connectsoft tissue such as connective tissue to the bone tissue as discussed ingreater detail below. Alternatively the suture thread 10 may be cut atthe closed loop 36 to provide two separate pieces of suture threadpassing through bone tunnels 44 and 54, which may both be connect softtissue such as connective tissue to the bone tissue.

In certain instances, suture thread 10 may rub and chafe (wear away)against bone 50, particularly at abrasive corners or edges, for exampleof bone bores 44 and 54 at openings 42 and 52, respectively, which maycause the suture thread 10 to break prematurely. Alternatively, if thesuture thread 10 is used in conjunction with soft tissue, the suturethread 10 may migrate and “cut through” the soft tissue.

Referring now to FIGS. 11-13, the suture thread 10 of the presentdisclosure, with or without the stiffening agent 20, may be used inconjunction with one or more hollow suture reinforcing tubes 80 a, 80 band 80 c, which may provide a cylindrical sheath around at least aportion of the length of the suture thread 10. As best shown in FIG. 11,suture thread 10 may extend through the lumen 82 of a flexible suturetube 80 a and extend from each end thereof. Suture tubes 80 a, 80 b and80 c may be made have a braided filament tubular structure, which may bemade of polytetrafluoroethylene.

In the case of hard tissue, the suture tube 80 a, 80 b or 80 c mayshield the suture thread 10 from abrasive bone corners, or at otherlocations against which the suture thread 10 may rub and chafe. In thecase of soft tissue, cutting forces placed on the soft tissue by thesuture thread 10 may be distributed over the larger surface areaoccupied by the suture tube, which may reduce the likelihood of thesuture thread 10 from cutting or pulling though the soft tissue.

As shown in FIG. 11, suture tube 80 a may freely slide along suturethread 10 so that it may be freely positioned anywhere along the lengthof suture thread 10 during surgery. However such may be problematic whensuture thread 10 is passed through a narrow tissue aperture, forexample, which may be created by a needle to which the suture thread 10is connected and passes through. In such case, while it may be possibleto pass the suture thread 10 through the aperture created by the needle,the increased diameter of the suture tube 80 a may inhibit the suturetube 80 a from passing through the aperture.

Alternatively, as shown in FIG. 12, suture tube 80 b may be bonded (e.g.fused thermally or adhesively) to suture thread 10, for example, at eachend 84 thereof by heat staking as to be held in a fixed (stationary)position. Such may be useful to inhibit the suture tube 80 b from movingrelative to suture thread 10. Such may be desirable, for example, whensuture thread 10 is passed through a narrow aperture which may becreated by a needle to which the suture thread 10 is connected. Thesuture thread 10 may then be used to pull the suture tube 80 b throughthe aperture.

As shown in FIG. 13, suture tube 80 c may freely slide along suturethread 10 so that it may be positioned anywhere along the length ofsuture thread 10 during surgery, similar to suture tube 80 a. However,suture tube 80 c may further include attachment means 86, which maycomprise threads, to connect to the suture thread 10. As indicatedabove, such may be desirable, for example, when suture thread 10 ispassed through a narrow aperture which may be created by a needle towhich the suture thread 10 is connected. The suture thread 10 may thenbe used to pull the suture tube 80 c through the aperture.

Referring now to FIG. 14, suture tube 80, which may include any ofsuture tubes 80 a, 80 b or 80 c may be used in conjunction with one ormore localized reinforcement members 90 (e.g. buttress plates, pledgets)to further inhibit suture thread 10 from pulling through soft tissue 92in direction 94. Furthermore, as shown in FIG. 14, suture tube 80includes attachment means 86, which comprise threads, to connect to thesuture thread 10. As shown, when suture thread 10 is passed through anarrow aperture 96 which may be created by a needle 98 to which thesuture thread 10 is connected, the suture thread 10 may then be used topull the suture tube 80 through the aperture 96.

Thus, the present disclosure may provide a suture tube 80 a, 80 b or 80c to inhibit inadvertent damage to a suture thread 10 or to tissue 50 or92 contacted by the suture thread 10 (e.g. tissue held in place by thesuture thread 10 or through which the suture thread 10 may passthrough).

While the principles of the present disclosure have been describedherein, it is to be understood by those skilled in the art that thisdescription is made only by way of example and not as a limitation as tothe scope of the invention. The features and aspects described withreference to particular embodiments disclosed herein are susceptible tocombination and/or application with various other embodiments describedherein. Such combinations and/or applications of such described featuresand aspects to such other embodiments are contemplated herein. Otherembodiments are contemplated within the scope of the present inventionin addition to the exemplary embodiments shown and described herein.Modifications and substitutions by one of ordinary skill in the art areconsidered to be within the scope of the present invention, which is notto be limited except by the following claims.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in theclaims, should be understood to mean “either or both” of the elements soconjoined, i.e., elements that are conjunctively present in some casesand disjunctively present in other cases. Other elements may optionallybe present other than the elements specifically identified by the“and/or” clause, whether related or unrelated to those elementsspecifically identified, unless clearly indicated to the contrary.

All references, patents and patent applications and publications thatare cited or referred to in this application are incorporated in theirentirety herein by reference.

Additional disclosure in the format of claims is set forth below:

What is claimed is:
 1. A method to treat tissue comprising: advancing atleast one winding of a suture thread into a first opening of a tunnelformed in a patient's tissue; advancing a suture retrieving device intoa second opening of the tunnel; rotating at least one of the suturethread or the suture retrieving device to couple the suture thread tothe retrieving device within the tunnel; and removing a portion of thesuture thread from the second opening of the tunnel by removing thesuture retrieving device from the second opening of the tunnel.
 2. Themethod of claim 1 wherein: the tissue is bone tissue.
 3. The method ofclaim 2 further comprising: using the suture thread to connect softtissue to the bone tissue.
 4. The method of claim 1, wherein at least aportion of said suture thread includes a stiffening agent.
 5. The methodof claim 4 wherein: the stiffening agent comprises a polymer.
 6. Themethod of 4 wherein: the stiffening agent holds a position of thewindings stationary relative to one another.
 7. The method of claim 4,wherein said at least a portion of said suture thread is coated withsaid stiffening agent.
 8. The method of claim 1, wherein said tunnelincludes a first and a second portion intersecting with each other at anangle, said first and said second portions including said first and saidsecond openings, respectively.
 9. The method of claim 8, wherein saidangle is an acute angle.
 10. The method of claim 8, wherein said angleis a right angle.
 11. The method of claim 8, wherein said first portionand said second portions each have a first and a second differentlongitudinal axis.
 12. The method of claim 1, wherein prior to advancingsaid at least one winding of said suture thread into said first opening,said method further comprises advancing a suture sheath comprising atube having a lumen through said tunnel; and wherein said advancing saidat least one winding of said suture thread into said first openingfurther includes advancing said at least one winding of said suturethread into at least a portion of the lumen.
 13. The method of claim 1,wherein a portion of said suture thread includes a coil including saidplurality of windings, and wherein said suture thread further comprisesuncoiled terminal end sections at opposite ends of said coil.
 14. Themethod of claim 13 wherein: the windings define a passage extendingthrough the coil; and one of the terminal end sections extends throughthe passage such that a loop is provided at one end of the coil.
 15. Themethod of claim 14, wherein said portion of said suture thread removedfrom said second opening includes said loop, and wherein said methodfurther comprising cutting said loop to form a first and a second suturethread extending through said tunnel.
 16. The method of claim 14,wherein said suture retrieving device comprises helical coil extendingfrom a distal end of a shaft.
 17. The method of claim 16, wherein saidrotating at least one of the suture thread or the suture retrievingdevice to couple the suture thread to the retrieving device within thetunnel comprises rotating said helical coil of said retrieving deviceuntil a portion of said at least one of winding of the suture thread ishooked by said coil of said suture retrieving device.
 18. The method ofclaim 16, wherein said rotating at least one of the suture thread or thesuture retrieving device to couple the suture thread to the retrievingdevice within the tunnel comprises rotating said suture coil until saidat least one winding passes between two adjacent windings of saidhelical coil.
 19. The method of claim 16, wherein a distal end of saidhelical coil projects distally.
 20. The method of claim 16, wherein adistal end of said helical coil arcs proximally to form a hook.